MAUDE Adverse Event Report: COOK INC FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH; GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation (2001)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the physician performed a diagnostic ureteroscopy procedure on a patient by using flexor 180 deflecting ureteral access sheath and vueoptic 150cm fiber optic bundle devices together.During the sheath advancement, the physician noticed the ureter was perforated due to larger outer lumen of the flexor 180 deflecting ureteral access sheath and lack of appropriate flexion.No section of the device remained inside the patient¿s body.The physician was unable to complete the procedure.A stent and repeat diagnostic urs was scheduled for the patient.This med watch report is for flexor 180 deflecting ureteral access sheath.Please see mdr # 1820334-2017-00887 for the second device (vueoptic 150cm fiber optic bundle) used on this patient.

Manufacturer Narrative

Investigation - evaluation.A review of the complaint history, device history record, instructions for use, and specifications was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The instructions for use provides numerous steps on proper procedures during use to ensure performance of the device.The ifu states under precautions, " in the event of resistance, do not force the deflecting mechanism." based on the provided information, no product returned, and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH
• Type of Device: GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6537295
• MDR Text Key: 74203904
• Report Number: 1820334-2017-00675
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00827002509740
• UDI-Public: (01)00827002509740(17)171010(10)5353204
• Combination Product (y/n): N
• Reporter Country Code: BC
• PMA/PMN Number: K072521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: FVAS-090075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Date Device Manufactured: 10/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other